TW201216951A - Oral dosing device for administration of medication - Google Patents

Abstract

A device for administering orally particles of medication and a liquid to a patient. In a first embodiment, the device has a medicine chamber and a liquid chamber. In a second embodiment, the device has a package and an ampoule. The device assures safe and relatively long-term storage of a medicinal product; provides an administration vehicle; prepares particles of medication suspended in a liquid; and improves patient compliance. A method of administering the medication entails using the disclosed devices.

Description

201216951 VI. Description of the Invention: TECHNICAL FIELD OF THE INVENTION The present invention generally relates to a device for supplying a drug to a patient. More particularly, the present invention relates to a device for supplying a drug to a patient, wherein the device allows the drug to be stored in the device in the form of drug particles suspended in the liquid, and the device is used to improve patient cooperation. The patient's condition is oral medication. Eight [Prior Art], appropriate administration of patients is an important consideration in the field of medicine. Especially for the administration of infants or smaller children: problems have arisen during the supply of fluid substances (e.g., liquid medicines) for many devices that are inconvenient for mobility and for the care of small animals and pets. The term "patient, as used herein, is intended to encompass infants, people with reduced mobility, small animals (helmet hopper +> house or garden care), and home; or smart = race). As is known to those skilled in the art The corpus callosum is provided to the patient in a variety of ways; and through the skin. The service, the main shot, especially the oral administration of the child, is difficult, for example, when it is necessary to supply a quantitative Chinese, sa is only used with a spoon. The spoon can be ίί. The usual method is a common household spoon, but the dose is only: If the child takes the medicine and does not have anything, it may raise the 'loss and provide more medicine to catch the H. If the medicine smells bad, 201216951 then This effect can be increased. The dropper can be used for oral administration. This device consists of a spherical head (usually made of rubber) and attached to one end of the tube. The other end of the tube has an opening into which the liquid can enter. Applying pressure on the bulbous head 'put the open end of the tube into the liquid and then releasing the pressure' then a certain amount of liquid is drawn into the tube. So 'when the liquid leaves the tube only through the opening at the end of the tube, The dropper provides some dose for directional control. However, because continuous pressure must be applied to the globular head to hold the liquid inside the tube, only one hand remains free' can properly position the dropper in the child's mouth. It is necessary to be very careful to ensure that the correct number of droplets is supplied. A number of other devices have been developed which are convenient for the supply of oral liquid medicaments. For example, U.S. Patent No. 5,431,680, issued to J. a piston slidably mounted in the container for supplying an oral liquid. The piston is operative to dispense a liquid through the outlet, the outlet being at least partially surrounded by a radially extending outer cover. U.S. Patent No. 6,981,962 to Lenkersdorf discloses U.S. Patent No. 7,399,295, which is selectively used for simultaneous oral administration to enbU1*g. The drug injector has a plurality of doses in a sealed storage chamber formed between concentric walls.

A set with a single dose of drug; == transfer chamber can be used to restore the body of the capsule. In the case where the piston is in the first position, the condition of the plug in the second position is closed under the condition of the illusion, and the transport chamber is filled with a single dose of medicine 4 201216951 1 . With the piston in the third position, a dose of drug is ejected from the transfer chamber through the injection port. Typically, a syringe is used to inject a drug through a needle, where the needle is the skin. In particular, when the drug is supplied by itself or the members of the Eighth Family are supplying the drug, the syringe face ensures the exact dose of the drug injected by the syringe. In many cases, the doses of the various injections are critical, although such syringes are labeled with a scale for indicating the dose. 'But the user is still fairly easy to read the wrong injection, and thus injects an insufficient dose or an excessive dose of the drug. . Even the cause can cause misreading syringe readings, including syringes, blurred marks, dimly lit, simply careless, inexperienced ▲ users or injecting personnel to a certain extent, poor vision. U.S. Patent No. 3,965,945 issued to Ross, and U.S. Patent No. 7,47,259, issued to H.S.A.Jr., utilizes a needle/injection of a drug to solve the problem. The present invention does not use needles, does not inject drugs through the skin, and does not rely on scales, because of these problems. Another example of a syringe and a method for supplying a patient's mouth is disclosed in U.S. Patent No. 4,784,641, issued to A. The dispensing end of the syringe includes a sleeve of sufficient size and approximate nipple shape to provide a supply surface that promotes normal suction of the patient. The downstream end of the cannula has a restriction orifice to limit the flow rate of fluid material flowing from the syringe, thereby preventing patient gagging and allowing the patient to safely inhale fluid material from the syringe in a controlled manner. w The lid is typically used in conjunction with a syringe to tightly close the opening of the injecting body. This lid helps to ensure that the medicine contained in the syringe is sterile. An example of such a cover is disclosed in U.S. Patent No. 4,286,591 to the name of U.S. Pat. Teach, install the syringe to fill the syringe to prepare for storage. Install the needle on the syringe before applying the fluid. It can be deflated without incurring the risk of sterility of the syringe. Port ί 2 introduces an end-opening end cap that encloses the syringe body with a syringe end cap having a fixed/luer lock (iuei>iGek) adapter to secure the syringe end cap to the end of the syringe body. U.S. Patent No. 5,125,415 to Bell, which teaches a <RTI ID=0.0>>><>><>> end cap, which includes a hydrophilic self-sealing filter for preventing S = to the syringe. After two accurate arterial blood gas samples, they are blocked because of the injection. After obtaining the blood (4), from the injection of ifSi, and then screwing the syringe cover to the syringe? Pick up, on. The male luer adapter of the syringe is attached to the female screw-on luer connector of the Ξ + 缟 cover only. When the tip of the syringe is raised upwards to raise the air to the Luer end, the spoiled plug is advanced to vent the air from the syringe body end cap. After the air passes through the device, the blood contacts the filter, and the filter expands due to the hydrophilicity of the filter. The expansion then creates a seal that prevents the air from flowing back into the blood sample. U.S. Patent No. 4,137,917 to the entire disclosure of the entire disclosure of the entire disclosure of the disclosure of the disclosure of the entire disclosure of the disclosure of the disclosure of the disclosure of the entire disclosure of It is the part of ^^ that is closest to the position where the needle is mounted. The filter unit t includes separate filters, each of which is used separately in the three parts of the injection side f. For each part of the method, the user pushes the appropriate 201216951/caution unit toward the center of the syringe. The filter first completely filters the air entering the solution. , filter down the solution pumped into the syringe. Finally, because the Lok solution passes through the third filter on the way to the patient, the solution in the syringe is doubled. ^ When the granule drug is sprinkled on a small amount of favorite food (for example, applesauce) and the patient is fed with a spoon. However, in the case of oral administration of the drug to children and children, the device is generally considered to be the best means of supplying the drug to the patient, f. For such an injector device, the arrangement of the particulate medicament f in the syringe for the supply of the medicament may be problematic. Syringe-related problems are usually made by the sr. The other 8 patents describe the design of some granular drugs in oral form through the patient's stomach, but do! : ί 儿 and children are suitable for these granules. However, placing the granules in the injection method requires that the closure be placed at the end of the syringe. The liquids and drugs in the ! will not flow through: Mountain II. Once the liquid and drug are added to the syringe, it is difficult to put it back into the syringe body without granulating the drug or both. In addition, it is difficult to reinsert the liquid in the case of liquid and drug, without ejecting the closure cap and plugging the contents of the syringe.

GlaxoSmithKline pic (headquartered in the British v. device. As shown in the figure, the six-segment granule drug delivery n carries the first step, where the caregiver or user 〇4 heads "ί 201216951 direction (for example, counterclockwise) 浐 her The top of a 14 Π, so take the second step of the body 〗 6, which uses the following: 27 ^ such as, clockwise) 捭 捭 + drag 4 & front of the direction of the B (example drug falls into the vial 14 Τ The top of the liquid] 2' thus causes the direction of the particle head "C" to be repeated, wherein the user 10 mixes along the arrow liquid 16 and produces a county float, 14, which causes the granule drug 20 and the spurt, wherein the fourth is recorded using Figure 1D. The top 12 of the bottle bottle is screwed again in the direction of the punching - the full take = 0 to include a large number of independent parts. It is ready to produce a large number of steps. In addition, the door requires the user to perform ideally. The patient does not deliver the suspension most often. There is still a need in the art for a more specific low-contaminated oral drug granule. Despite the various designs of the syringe and cap, such as the devices disclosed in the above patents and the disadvantages of the LH! existing solution, provision is provided. The drug comprises a liquid mixture containing particles or drug particles suspended in a liquid. The main object of the present invention is to provide a modified oral administration device for a patient which can be safely and carefully supplied. A further object of the present invention is to provide an oral delivery device which can be supplied to a patient who is minimal, youngest and least cooperative in size and shape. The related object is to provide an improved oral administration in 201216951. The required flow rate of the device device J is not = the patient U is guaranteed to be from the device, is provided with an oral drug delivery device, and is provided by a conventional material and manufacturing technique. Use, economical and ready to go: Ming Hai is the one that will supply the user with granular drugs or contains the least amount of drugs. The number of steps required for the composition of the alpha fly or both is reduced to a purpose to provide an improved oral addition , (1) to ensure safe and longer-term side products; (2) to provide a supply carrier; (3) to make drugs = suspended in liquid; and (4) to change The compatibility of good patients' related purpose is to make the solid drug production = body J 2, and to ensure the appropriate shelf life before the supply time of the drug product = supply time. Additional relevant, 疋k for simple and expedient Procedure, which is easy to apply when the user does not (or rarely) prepare or practice in advance, while preserving the quality and efficacy of the drug. Another related purpose is to avoid direct manipulation or contamination of the drug or damage to the drug. A related objective is to avoid the need for foreign tools and to provide a portable, easy to operate and separate device. The present invention also has the object of providing an improved method of supplying precise doses of granular drugs to different groups of patients, including the paediatric population. A more precise dose of the drug can be supplied by avoiding the aforementioned disadvantages associated with drug measurement. Specifically, the oral administration device of the present invention supplies a precise dose of granules to small children and infants. The additional purpose is to allow the user to take the medication alone. Specifically, the oral administration device of the present invention provides a granule drug for patients with cystic fibrosis of 201216951 = dysfunction characterized by a decrease in the amount of protein, and a small degree of absorption of carbohydrates. Secretion of pancreatic insufficiency results in limited use of the pancreatic digestive drug delivery device due to fluid secretion, and less obstruction of the pancreas. This provides an improved supply of granular drug for the treatment of exocrine insufficiency. With regard to all of the foregoing, the present invention is directed to an effective, useful, and low-cost drug. [Inventive content] Requires 2 Γ ίί and other objects #, meets these and others, and considers its use, the present invention provides A device suitable for oral drug particles for hanging in a liquid. In the example, the device has a drug chamber and a liquid to have an opening, and (b) a septum, which may include: (a) a housing that holds the liquid and Having a shape of -^^, the nipple has a hole and (b) a cover that seals the hole. One is adapted to be sealed with a sealing mechanism between the drug chamber and the liquid chamber; In the case of the λ λ example, the device has a package and an ampoule. The package (a) body, which encloses the liquid, and (b) the cover, and has a septum attached to the protrusion, the vine, including the housing, has A nipple-shaped head of one hole, the other end being connected to the main member suitable for the ampoules in a liquid-tight manner. The present invention also provides a method for administering a drug granule composition of the mouth 201216951 to a patient suspended in a liquid. In the first device, the method comprises the steps of: (a) removing the cover from the housing = hole; (b) sealing the seal between the drug chamber and the liquid chamber; (c) releasing the diaphragm to open 3 The granules leave the body and enter the liquid, which will: The method in which the drug chamber falls into the liquid chamber to move the drug chamber to the hole; and (4) the device for the particle liquid = even Γΐ Κ ,, the method includes Fi more steps. In the first step, the barrier is opened to release the drug into the body of the drug and the most: for the relative. For administration to the patient. The liquid composition of the ocean granules is described in the general description and the following detailed description of the invention is not intended to be limiting. [Embodiment] To be more detailed, the apparatus of the present invention includes two master tools. In the first embodiment of the present invention, as a product chamber, the drug chamber storage particle member is a drug added to the _H f 、 , , and provides a granular form. In the simple liquid of the liquid f) in this part 2, the package (individually: "a component is a package, which is to be suspended in a liquid. The material and the liquid are packaged to prevent the measurement from being appropriate". 2. Asking for screaming and preparing for difficulty with the ejector. The present invention also includes 11 201216951. An exemplary drug that requires the device and method to be easily implemented and not invented. The device of the first example is used. And the supply method two = = = diagram; !: describes a strict reference frame of the device 30, and all the parts including the views are the same components including the same reference numerals. Figure 2 = 2. The drug chamber 40 contains a drug particle sputum intercalating an exemplary granule drug. The liquid chamber 60 contains a liquid 98. The evaluation fluid f Γ can be any suitable genus commonly used to dispense a drug, etc.): if ? 98 (amount, viscosity, density, Surface tension ί 液体 Liquid 98 must avoid the block during the preparation process. Preferably, the liquid 98 is required in some way (for example, string ί 5 i makes the patient easy to accept 'and thus with the liquid 98 ί = 2% of the object must also be able to carry Transfer ίϊϊί: Appropriate liquid 98 includes milk, formula, i other ίίί, and juice (for example, apple juice, grape juice medicinal liquid composition. 预 pre pre μ μ it medicine, chamber 40, drug chamber 40 has encapsulated particles In a preferred embodiment, body 42 has a slit L = ϋ 4° diaphragm 58 sealing opening 56 to prevent particles (10) β ^. Although various materials of construction are possible, they are preferably relatively thin. Made of aluminum, thinner aluminum ί 100 M pq, cracked or peeled off, thereby opening the opening 56 and connecting the 1拄34 main body 42° to the liquid chamber 60 in the drug chamber 40, the diaphragm 58 preventing the particles 100 from contacting The outside world also separates the particles 201216951 100 from the liquid 98. As shown in Figure 2, the mask 50 includes mechanisms (e.g., 40 also has a cover 50. The pair of pockets on the outer chamber 60: ^thread 52) 6 〇在-起: 单单上= drug chamber 4 〇 and liquid chamber hole 46. Early 70. The outer cover 50 defines a cylinder I at its lower end i: 〇4f f preferably substantially circular and body The construction-body body Hi cover preferably has an integral one - its full mouth right body is too much An integral part, the other part - is a part = 62 and 6 has a housing 62 that holds the liquid 98. The outer casing is opposite the bottom... The cover 48 Ϊ f head '44 has at least one hole 66. The nipple m prevents the liquid 1198 from leaving the outer casing 62. The aperture 66 of the crucible has a predetermined cross-sectional area that is disposed within the outer casing 62 from the aperture 66 during the crucible: the music is predetermined, and is predetermined, and thus the predetermined special, that is, the determined 'ie' The prior bite is known at least in some event towels. The appropriate diameter of the dry 4 holes 66 ranges from about 2 mm to about 15 mm (preferably from 4 to 10 mm). It is also important that the cross-sectional area of the aperture % = the geometry of the nipple head 44 allows for the supply of the entire dose of medication. The outer casing 62 also has a structure (e.g., external thread 72) that engages with a corresponding mechanism on the drug chamber 4 to seal the drug chamber 40 and the liquid chamber 60 together as a unit. As a replacement for or in addition to the threads, the drug chamber 4 can be snap-on (Hn) on the liquid chamber 60 or by interference fit. (interference fit) is fixed to the liquid chamber 60. The volume of the drug compartment 40 should range from the conventional hard gelatin capsule 13 201216951. From size 3 (0.3 ml) to size 00 (〇95m, although for the supply of capsules, the size 〇〇 is considered to be the limit, but in patient compatibility On the other hand, a larger volume is also within the scope of the invention. Therefore, the device 3 can be used to supply 3-5 grams of product, corresponding to a liquid chamber of 6 〇 in a volume range of ml, or in a youth or adult population. In the case of even more. The present invention also provides a method of treating or preventing out-of-sequence. The method allows for rapid and accurate preparation of the drug within the device 30. Specifically, the device 30 can be used to enter a baby, a person or The fluid of the person inconvenient or other patient's mouth is supplied with the drug. Figure 3 is a typical procedure included in the exemplary embodiment of the method of the present invention. Figures 3A, 3B, 3C, 3D and 3E It can be noted that the drug particles can be prepared to be delivered to the patient in a relatively small number of steps. Figure 3A shows the first step in which 10 is oriented in the direction of arrow "A" (e.g., counterclockwise) Above the outer casing 62 The cover 48, thereby hitting = two with 2, and allowing the user 10 to use the liquid 98 through the aperture 66. Alternatively, the user 10 can peel off the cover in the direction of the arrow "D" to remove the cover 48 from the outer casing 62. 3B is not a second step in which the user 1 密封 seals the chamber 40 and the liquid chamber 60 together as a unit. Typically, the user 10 causes the drug chamber 4 to follow the arrow "E,, the square, the liquid The chamber 60 is moved (of course, the user can move the liquid toward the drug chamber 4 in a direction opposite to the arrow "E" or can move the drug chamber 40 and the liquid chamber 6 simultaneously toward each other). The mechanism above the chamber 40 and the structure above the liquid chamber 6〇, as shown in the figure, the user 1〇 rotates the music chamber 40 and the liquid chamber 6 relative to each other in the direction of the arrow "A". In order to make their corresponding threaded connection 201216951 Ϊ〇 1% of the 7%1: two-in-one drug chamber 40 in the liquid chamber structure to their combination, it is important to pass the object: think the object room"吏用者. The third step of taking the medicine, so that m: the part of the to make

To the patient, you need to: set the total number of steps required to prepare the drug. However, as shown in Figure 3C, the user is pushed down. 用 User 1 落 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着 沿着The object is pulled 100 4 (〇. The cover is attached to the user 10 to screw the drug chamber to open, the result is to rupture, tear, strip I and open or release the barrier 58 ' to open 98. Allow particles 1 〇0 leaves the main body 42 to enter the liquid pull ΐ ΐ ΐ 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 They may initially be distributed in the liquid. Therefore, the drug particles 100 may fall behind to shake the device 30 to better distribute the particles 10 in the liquid 98. -f , 3D is not the fourth a step in which the user 1 turns the drug chamber 4 〇 in the direction of the front head 'A', thereby removing the drug chamber 0' to expose the hole 66 and opening the device 3〇. As shown in FIG. 3A, the music room 40 It is completely removed. 15 201216951 The body room is too much as shown in j 3E, the user W can adjust the liquid fi Γ 1 1 i, for example, as shown in the figure, reverse the liquid chamber 6 〇). The second group is combined with the mouth r: r flow. The suspension of the upper particles: the particles 100 and the liquid 98 are inserted into the string I μ away from the liquid chamber 6〇. By placing the nipple head 44 in the mouth and slightly squeezing the outer casing 62 of the liquid chamber 60, it is possible to easily suck the nipple head #44 at the resin or the patient's teeth. The user presses the outer casing 62 of the liquid chamber 6 to enter the patient's mouth. The transfer is continued or straight from the string is transferred from the liquid $60 to the patient, at which time the liquid chamber 60 is removed from the patient's mouth. The first example of the Ϊί step ^faf II with this / two: method is from the outer casing 62 containing the liquid 98 over ====; = «n?sir; (injection liquid: 98, so 荜t two (2) supplying the empty drug chamber to the patient's medicament, and (e) supplying the patient's medicament. The method of the present invention allows the supply of the drug to be accommodated in the specific example. To reduce the supply of pancreas and reduce the amount of phlegm and phlegm required for taking the drug. The caregiver uses familiar tools and • ΐί ϊ γ people's help ° The supply of drugs is basically not Λ, patient Willing to accept the medication being taken, and 201216951 ΐϊϊ will not refuse or spit out the drug, chew or protect the drug, but not swallow or show signs of pain (Example 1! Hold the nipple head as shown in Figure 2) The portion 44 having a right circular nipple-like head portion 4 4 may also be in the shape of a funnel cylinder. It may also be constructed and arranged to provide a supply surface for attracting the fennel portion 44. The drug particles 1 〇 0, liquid are taken at f %等等, 斤心切-s Ϊ Ϊ and as shown in Figure 2, the nipple head 44 can be inserted into the nipple head 44:? 4A is not a nipple shape): Figure ΛΒΓ is a first example of a second alternative nipple shape. The nipple head 44 and right $, 卜 13 and preferably have a plurality of holes 66; : Large: d: up to the patient. Each hole 66 is a metering distribution hole, and the second: P: the flow rate of the knife that flows out from the liquid g 60 is not too high to cause the patient to reach. The second example of the W body 98 A schematic representation of an example of a device component and a supply method. The package has a 9 f =1 package (4) containing a liquid 3 and a cover 84 and the liquid 98 is sealed in the body 82. Packing = Γ [4 shows: seal 86, when the user 10 is threaded from the main body, and: fruit and *84 have corresponding if the sample 'user 10' by rotating (ie, 201216951 unscrew the ^ tube 84 from the main body 82 is removed from the cover 84. The 臈 58 has a diaphragm 58 that is connected to the protrusion 88. The diaphragm 58 defines a space containing the particles 100. The spacer 98 separates the particles 1 〇 0 from the outside and makes the life The vertical 100 and the liquid milk have, %, the end of the housing 92 has a necessity, and the ?η兮Ί has 70 pieces. Usually, although the body of the 80 is not installed = the pattern 94' Package 94 and the thread

Γ 9 : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : ΐίΐΐΐΐThe nipple head 44 has been inserted' so there is no possibility of harming the patient's roundness. Another advantage of the 96 is that when the brother is over the degree, the shoulder 9G will not interfere with the i The shape of the rr body has an integral one-piece configuration: the gas thread 94 preferably has many functions: by preventing the nipple-like [forming structure to achieve a continuous formation, the two dimensions and the volume of the liquid 98 to be supplied and the ΐ =: Compared to the 201216951 example. The usual volume range is 3-5 children or young children) to 20 m 1 ί more 』=, the product is suitable for infants and is suitable for adult groups). The larger body of 5 〇ml is as shown in Figures 6A, 6B and 6; the shock 30 is relatively less plastic; it is delivered to the patient using Figure 5. Figure 6:; quasi = drug 10, please push the drug from the diaphragm 58 "two = push down the direction of J" 1 cover arrow "Ε" The result is rupture, tearing and peeling cover peeling 8 2 5 with 8 When it is combined, tr enters the liquid 98'. Optional =, when the liquid can be shaken in the method, in order to facilitate the shape of the cover = = invitation = where the user 丨〇 rotation on behalf of the body 82 on the full body 82 particles 1 〇〇 and liquid ^ Open the body 82. In this step, the heartbeat is detected by the address and the hit is provided to provide the offset: =12 shows the unsealing seal 86, information. Here; J uses the (four) joint of the open body (2). Usually, ===?= [〇 The corresponding pattern on the two parts of the J J : : 为 。 。 。 。 。 。 。 。 。 。 。 Located in the main body Πΐ 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 经 ( ( ( ( ( ( ( ( ( ( ( ( ( With the liquid 98, by gravity, the user 10 is transported or supplied to the patient by the kind of 201216951, and the device 30 is opened by the nipple-like head 44. The direction in which the nipple head 44 is engaged to the housing of the ampoules 90 is slightly 1. This action is required if the patient does not fit or is unable to suck. In summary, a second example of the method of the invention using the device 30 ί (1) releasing the space defined by the diaphragm 3 into the liquid 98 in the body 82 by opening or releasing the diaphragm 58; (b) opening the lid 84 from the body 82, thereby exposing the particles in the body 82 1〇〇 and the liquid 98 move and open the body 82, then engage the ampoule 9〇 with the main body 82, thereby replacing the cover 84 on the main body 82 with the ampoule 9; and (c) supplying the patient's medicine. According to the second example The method enjoys many benefits as a first instance feature And advantages. C. Example Drugs Provided The above device 30 can be used to supply a number of drugs. Aptalis Pharma sells at least a portion of these drugs. For example, Aptalis Pharma is marketed under the designation EUR-1008 and the registered trademark Zenpep® for the treatment of pancreas. Delayed release capsules in patients with exocrine insufficiency (EPI) The US Food and Drug Administration (FDA) estimates that more than 200,000 Americans have EPI. EPI is unable to properly digest food due to the lack of digestive enzymes produced by the pancreas. Deletion leads to indigestion and malnutrition, which is common in 201216951 people with cystic fibrosis (CF) and other conditions that threaten the exocrine function of the pancreas (eg, pancreatic cancer, gastrointestinal surgery, and chronic pancreatitis) Disorders. EPI causes malnutrition, especially leading to CF, impeding child growth, jeopardizing immune response, and shortening life expectancy.

Aptalis Pharma pharmaceutical preparations supplement missing enzymes, improve digestion and absorption and meet USP standards. Each capsule of Zenpep® and EUR-1008 capsules contains a small enteric-coated bead of a concentrate of porcine enzymes, which comprises a composition of pancrelipase, which is mainly dry gland lipase (main) Pancreatic enzymes lipase), a mixture of proteases and amylases. Inactive ingredients of Zenpep_〇EUR-1008 include crosslinked hydroxymethylcellulose sodium, hydrogenated cannabis oil, colloidal cerium oxide, microcrystalline cellulose, magnesium stearate, propylcellulose phthalate, hydrazine Magnesium acid and triethyl vinegar. More detailed information regarding Aptalis Pharma pharmaceutical formulations can be obtained from U.S. Patent No. 7,658,918, the disclosure of which is incorporated herein in its entirety. Each dose of Aptalis Pharma pharmaceutical formulation provides patients and physicians with a consistent amount of digestive enzymes, a highly stable formulation of dry pancreatic lipase, protease, and amylase. The capsule can be opened and the contents separated to titrate the medicament separately. These features allow health care professionals to fine-tune treatment regimens to achieve optimal symptom control with improved dose accuracy. In addition, it may reduce the patient's drug burden. The device 30 of the present invention can be used in any suitable digestion composition. The present invention can be applied to a seawater particle 100 comprising a digestive enzyme synthesis. Preferably the particles 100 are coated particles. "Particle 100 can have any suitable size or shape. Particles" This term can include tablets, spheres, pellets, tablets, microtablets, microparticles, microspheres, microcapsules, and microspheres. The term "particles" as used herein, includes particles of 21 201216951 having a diameter ranging from about 1 μηι to a pellet having a diameter of about 5 mm. For example, the particle size of the particles may range from about 5 μμηι to about 5,000. _, or from about 50 μm to about 2 μm, their nominal, (e.g., average) particle diameters may range from about 2 to about 5 mm 'or less than about 2 mm (e.g., from about 5 to about 2 mm). It may have a diameter of, for example, from about 〇7 to about i6 mm or about 〇7 to about 1.25 mm. It is also suitable for "microspheres having a minimum mean particle size value of about 1.15 mm, or a maximum mean particle size of about 2.63. The "micro-pill" of mm may have an average particle size of less than about 800 μηι, preferably less than about 5 μμηι, more preferably from about Ομμιη to about 60 〇μηι, or from about 25 μm to about 5 〇〇μιη. f-beads may have a volume diameter d (v, Gl) (defined as a volume of 10% of the cloth below this value and 9〇% above the diameter of the value) not less than 400 from 〇1, volume Diameter 〇1 (¥, 〇9) (defined as 90% of the volume distribution below this value and 1〇% above this value The diameter) is not more than 900 μη. The digestive enzyme granules used in the device 3 of the present invention are preferably formed with the coated particles 100. The coating can be predetermined to guide the drug to the patient in the most effective drug. The coating may be predetermined prior to the administration of the drug, for example, to dissolve in the blood, stomach, intestines, or any other suitable location. In an emphasized example, the drug is coated with an intestinal (or enteral) polymer. The term "enteric polymer" refers to a polymer that prevents the digestive enzyme from contacting the stomach, such as a polymer that is stable under acidic pH but rapidly decomposes at a lower pH, or the following polymer: with the stomach-intestine Conversely, the remainder of the track, the polymer has a low rate of hydration or erosion, and is sufficient to ensure less contact of the contents of the stomach with the enzyme in the stomach. Thus, the granules 100 used in the device 30 of the present invention are coated with a barrier to prevent the drug from contacting the acidic environment of the stomach for use in 201216951, and substantially prevent the release of the drug prior to reaching the small intestine. The individual particles 100 may all have the same coating composition, or may include a blend in which some of the particles 100 have different coating compositions. Any suitable combination of coating ingredients can be used to provide the desired type of release or therapeutic effect. In order to avoid irritation of the oral mucosa and inactivation of the enzyme, the particles of Zenpep® should not be chewed or contained in the mouth. The lipase activity of the compositions used in device 30 of the present invention may range from about 650 to about 45,000 USP units, from about 675 to about 825 USP units, from about 2,700 to about 3,300 USP units, from about 4,500 to about 5,500 USP units, about 9,000 to about U,000 USP units, about 13,500 to about 16,500 USP units, about 18,000 to about 22, 〇〇〇USP units, about 22,500 to about 27,500 USP units, about 36,000 to about 44,000 USP units' and between them All ranges and sub-ranges. Enzymatic assays of compositions expressed in USP units were performed according to the Usp protocol. The '‘USP’' unit used in the United States measures drug efficacy, its expected biological effect. "USP" is a registered trademark of United States Pharmacopeial Conve.ntion, Inc., which is a private standard structure for establishing standards for the pharmaceutical industry. The amylase activity of the compositions used in device 30 of the present invention may range from about 1,600 to about 6,575 USP units, from about 6, to about 225,000 USP units (e.g., from about 6,400 to about 26,3 〇〇 USP units). , about 1〇, 7〇〇 to approximately 43,800 USP units, approximately 21,500 to approximately 87,500 USP units, approximately 32,100 to approximately 131,300 USP units, approximately 42,900 to approximately 175,000 USP units, approximately 53,600 to approximately 218,700 USP units, And all ranges and subranges between them. The composition used in the device of the present invention may have a protease activity of from about 1,250 to about 3,850 USP units, from about 5,000 to about 130,000 USP units 23 201216951 (eg, from about 5,000 to about 15,400 USP units), from about 8,400 to about 25,700. USP units, from about 16,800 to about 51,300 USP units, from about 25,000 to about 77,000 USP units, from about 33,500 to about 102,800 USP units, from about 41,800 USP units to about 128.300 USP units, and all ranges and sub-ranges between them. The lipase activity can range from about 675 to about 825 USP units, the amylase activity can range from about 1,6 to about 6,575 USP units and the protease activity can range from about 1,25 to about 3,850 USP units. The lipase activity may range from about 2,700 to about 3,300 USP units, and the enzyme activity may range from about 6,4 to about 26,300 USP units' and the protease activity may range from about 5 to about 15,400 USP units. Alternatively, the lipase activity may range from about 4,5 Å to about 5,500 USP units, the amylase activity may range from about 1 〇 7 至 to about 43,800 USP units, and the protease activity may range from about 8,400 to about 25,700 USP units. Alternatively, the lipase activity may range from about 9,000 to about 11, 〇〇〇 USP units, the amylase activity may range from about 21,500 to about 87,500 USP units, and the protease activity may range from about 16,800 to about 51,300 USP units. Alternatively, the lipase activity may range from about 13,500 to about 16,500 USP unit amylase activity may range from about 32,100 to about 131,300 USP units, and the protease activity may range from about 25,000 to about 77,000 USP units. The lipase activity can range from about 18 Å to about 22,000 USP units, the amylase activity can range from about 42,900 to about 175,000 USP units, and the protease activity can range from about 33,500 to about 102,600 USP units. The lipase activity may range from about 22,000 to about 27,500 USP units, the amylase activity may range from about 53,600 to about 218,700 USP units, and the protease activity may range from about 41,800 USP units to about 128.300 USP units. 24 201216951 The range of activity can be as defined by the lipase λλ of the composition used in A ^ n to about 5,000 PhEur lipase units to about 30,000 PhEur lipase units; they ^ 10,000, 15,000, I^I〇U〇〇4 〇^^ 30,000 or about 40, 〇〇〇PhEur lipase unit. '彳萨如' is not the European Pharmacopoeia (PhEur) is a list of the use of the composition used in Europe ίίΓί?=30: enzyme can be packaged

Ui)d (: a lipase, or two or multipathic lipase), one or more amylases (ie one box of tortoise, one or more amylases), one or more "ΪΓ:, or more a mixture of proteases. The ratio of amylase:lipase in group 1 used in the device 3 可以 can be from about 1 to about 1 〇, and the amount of ΐ 2 1 can be from about ί to about 8:::, Enzyme: The ratio of lipase is about 86 to about 5.38 according to the USP protocol (for example, to determine the enzyme detection) ° at a ratio of even 1 眚 lipase activity is about i, about 2 3 ', ',, ' About 5, about 6, about 7, about 8, about 9, or about; 〇,: D. The example kit gets gentry ΐ ii.:. 部合 = 吏i user 1 〇 = package 7:= Can be manufactured in - from the second set = in addition to the Λ can be made together to form a drug. According to the real two examples of particles two t in the medicine, room 4 〇 or = ^ ^ ^,,,, material combination 1 And the various parts of the device 30 201216951 may be glass, rubber, etc., but the device 3 〇 preferably slippery, rigid, non-toxic, synthetic plastic material shape can be made using a wide range of standard plastic materials. Device 3 parts, provided these materials are chemically compatible with the product. σ Polyethylene glycolate (ΡΕΤ) is a heat of the polyester family. Plastic polya resin and used in liquid containers. Polypropylene Πΐί The polymer is used in a wide range of U-packages. Density polyethylene (HDPE) is stone, thermoplastic polyethylene made from sword; low-density polyethylene (LDp / 曰^ oil thermoplastic thermoplastic) Plastic. Polyethylene (pE疋 widely used plastic, the annual output is about metric 8 It mainly uses it including packaging. pET, PE and pp are the most useful materials for manufacturing, 30 parts. Hard plastic material (PET\ PP and HDPE) is particularly preferred for the manufacture of packages. The glue (4), when touched and recorded, uses PP and LDPE to achieve these characteristics. The body 42 of the eight drug room 40 and the ampoule The ground is transparent, allowing the user 10 to see its contents. The main, month and ampoule 90 can also be colored or have other indicia to provide information, such as £3 = week = medication should be supplied, etc. : On the construction of Ke Village, the device 30 does not need to be school . Outlet unit: towards the ί shall ". In A: ,, moisture proof packaging board" language permeability to water of less than about billion · 5 mg pouch of water; the composition may also comprise a blister pack can

The desiccant inside the humidity (ie, water absorption, = J adsorption water «), ❹ energy _ (four) in the packaged into the person's 201216951 air to remove the "moisture desiccant capsule. Will be described ί It will be seen that the present invention provides several important advantages. 2. The present invention provides an improved oral delivery device for use in infants, the elderly, and the elderly. The shape and size of the Μ' provides the patient with suction and ^ The supply surface of the f-object does not overflow and is accompanied by a 'drug-transmitting wound. In addition, the nipple-like head 5 is not fast enough for the patient to reach. Additional functional advantages of the spread of the flow-out flow ηΐί 30 include (1) Entering, communicating, storing drug products (for example, at room temperature (2_) 3 γ. (7) = giving the carrier; (3) making the drug $ (4) in the body for oral administration of pediatric donors; And (5) the material forming device 3 改 改 改 , , , , , , , , , , , , , , , , , , , , , , , , 以及 以及 以及 以及 以及 以及 以及 以及 以及 以及 以及 以及 以及 以及 以及 以及 以及 以及By: lower: and temporary, the order 'save at the same time = the effect. Hunting by avoiding the direct fall of the drug + σ drug to achieve the preservation effect. Chestnut made / can be wood or damaged

Among other features, by direct and simple mouth opening, the drug delivery function 1 sets 3G and transmits young, H S3 mesh including its nipple shape. What is desired is the supply of the required dose in the infant. ^With the intersection and the whole 27 201216951 Among other features, the function of improving the patient's fit is achieved by the following means: no temporary tools (for example, sputum), a surveyor, a syringe, etc. are required. The device 3 is still portable and the easy device 30 is separate. These features make the device 30 ideal for men and women as well as other patients. While the invention has been shown and described with reference to the specific embodiments embodiments On the contrary, the scope and scope of the = and the spirit of the present invention can be applied to the details 2, and it is clear that all the ranges widely quoted herein are included in the scope of the scope. A narrower range. BRIEF DESCRIPTION OF THE DRAWINGS The invention will be best understood from the following detailed description. It is emphasized that the size of the 4 by = medium: ^ feature can be arbitrarily expanded or reduced. And it is the ^' on the red one of the ^ s' baskets on the surface of the basket or in the bottom of each. In the following figures: 卞伐和体 Figure 1A shows a five-step procedure by which a commercially viable first-step drug is delivered to a patient; The granules are shown to comprise five steps by which a commercially available first-step drug is delivered to the patient; 侍 the sputum preparation σ prepares the granule Figure 1C to be a side comprising five steps, by Step, commercially desirable: the third step of the delivery of the music to the patient; production ° " preparation of the particle map (1) shown as a four-step method of the fourth step 28 201216951 "by this step, commercially available The enemy drug is delivered to the patient; ', the transmission σσ preparation shows the particle as a method comprising five steps f # From this step, the commercially available drug is delivered to the patient; for the agricultural (10) + preparation of the particles and liquid = The first embodiment of the present invention includes a drug chamber f f f f 3A showing a first step of a method of preparing a musical substance for delivery to a patient using the apparatus shown in FIG. 2; and a granule as shown in FIG. The second step of the method of delivering the musical instrument to the patient ^ Prepare the granule drug with the second part of the = usage map of the 2nd part of the preparation ~ Prepare the second step of the particle m - Λ (optional step); 筚 you f prepare the beam for use with the device shown in Figure 2. The fourth step of the method of delivering the object to the patient; the last step of the method of transmitting the device to the patient using the device shown in FIG. 2 is shown in the riding frame j 3E, and the particle shaking portion is shown as The nipple-like shape of the first example of the invention is shown as a second embodiment according to the second embodiment of the present invention. According to the second example of the present invention, the package includes 1 ^ ^ ^ ^ ^ 29 201216951 [Major component symbol description] 10 user 12 Top 14 vials 16 liquid 20 granules drug 30 device 40 drug room 42 body 44 nipple head 46 孑 L 48 cover 50 cover 52 internal thread 54 bottom 56 opening 58 diaphragm 60 liquid chamber 62 housing 64 bottom 66 hole 72 external thread 80 packaging 82 main body 84 cover 86 shows unsealing seal 88 protrusion 90 ampoules 92 housing 94 thread 201216951 96 shoulder 98 liquid 100 drug particles

Claims (1)

201216951 VII. Patent application scope: A device suitable for supplying a patient to a suspension in a body, the device comprising: a drug chamber comprising: (a) a housing having a sealing mechanism, (b) a body at least partially retained within the housing And the particles have a bottom with an opening, and a mouth to prevent the particles (c) from being detachably sealed from the body; and a liquid chamber comprising: (a) - an outer casing 'It holds the liquid and has a sealing structure and/or a perforated nipple-like head that engages with the sealing mechanism to removably seal the drug chamber and the liquid chamber into a unit' and (b) - a cover that seals the hole. 2. The skirt according to item 1 of the patent application, wherein the drug particles are particles containing digestive enzymes. 3. The device according to claim i, wherein the liquid is at least one of the following: milk, formula, flavored syrup or water, fruit juice, or a liquid composition of a predetermined pharmaceutical dosage specially designed to ensure complete recovery. 4. The device of claim 1, wherein the membrane is made of relatively thin, which can be easily broken, torn or stripped to open the opening and allow the particles to exit the body. The device of claim 1, wherein the body and the outer cover are integral. 6. The device of claim 1, wherein the nipple-shaped aperture has a predetermined cross-sectional area adapted to dispense a drug disposed in the housing during use of the device. 7 method for supplying a patient with oral drug particles suspended in a liquid using the device of claim 1 for the method, the method comprising the steps of: (a) removing the cover from the hole of the outer casing; (b) in the drug Forming a seal between the chamber and the liquid chamber; (/) releasing the membrane to open the opening and allowing the particles to exit the body of the cartridge into the liquid such that the drug particles fall from the drug chamber into the liquid in the liquid chamber (d) removing the drug chamber to expose the hole; and (to supply the drug particles and liquid to the patient. = according to the method of claim 7 of the patent application, * in the drug room = liquid chamber The step of forming a seal between: the cells are occluded to the liquid chamber, and the person sliding the drug chamber to the liquid 宕p. The body is up to cause friction or interference. After the step of applying for the patented granules, it is disposed in the liquid. The method of item 7 wherein the granules are gathered to make the granules well-divided 33 9 201216951 10 · According to the scope of the patent application 7 items The method wherein the step of supplying the drug particles and liquid to the patient comprises inserting the papillary head into the patient's mouth and slightly squeezing the outer shell of the liquid chamber. 11. A device suitable for supplying a patient to be suspended in a liquid An oral drug granule device comprising: a package comprising: (a) a body enclosing the liquid, and (b) a cover sealing the body and having a septum connecting a protrusion, the diaphragm defining the package a space for the granules; and (a ampule-ampule, comprising a casing having a nipple-shaped head having a hole at one end and an element at the other end, the element being adapted to connect the ampule in a liquid-tight manner The apparatus according to the third aspect of the patent application, wherein the drug particles are particles containing digestive enzymes. 13 column 1, the device of claim 11 wherein the liquid is lower/at least one type: Milk, formula, flavored syrup or water, juice, a device designed to ensure a fully reconstituted predetermined dose of liquid cypress needles, application no. 11, The separator is made of, thick, which can be easily broken, torn or peeled off and allows the particles to leave the body. There is a device according to claim 11 wherein the package 4 The seal of the unsealed seal, which is ruptured when the cover is removed from the body. The device of claim 5, wherein the hole of the nipple head has a predetermined cross-sectional area The cross-sectional area is adapted to dispense a drug disposed in the ampoules during use of the device. 17. The device of claim 11 wherein the ampoule has a circle adapted to provide an abutment The abutment prevents the patient from inhaling the housing of the ampoule into the patient's mouth, the shoulder indicating that the papillary head has been inserted into the patient's zero depth, and when the papillary head is placed The shoulder avoids contact between the Δ海女瓶 and the shai patient's nose when the patient is in the mouth. 18 - A method for supplying a patient's oral oral drug particles floating in a liquid using the device of claim U, the method comprising: the following steps: (a) opening the membrane, the drug particles from the membrane The defined space is released into the liquid within the body; (b) replacing the lid on the body with the ampoule; and (c) supplying the drug particles and liquid to the patient. 19. The method according to claim 18, wherein after the step of releasing the drug particles, the package is shaken to better distribute the particles in the liquid. The method of claim 18, wherein the step of supplying the granules and liquid to the patient comprises inserting the nipple head into the patient's mouth and slightly squeezing the ampoules. 35